The aim of this study was to evaluate the efficacy, safety, flexibility, and ease of handling and use of the Ped3CB-A 300 mL, the first ready-to-use multichamber parenteral nutrition (PN) system, ...with optional lipid bag activation, specially designed for administration to preterm infants.
In this prospective, open-label, multicenter, noncomparative, phase III clinical trial, preterm infants were treated with Ped3CB-A for 5 to 10 consecutive days.
A total of 113 preterm infants were enrolled in the study and 97 (birth weight 1382 ± 520 g; gestational age 31.2 ± 2.5 weeks; postnatal age administration 5.6 ± 6.1 days) were included in the per protocol analysis accounting for 854 perfusion days. Double-chamber bag activation was used for 32 perfusion days. Macronutrient, electrolyte, and mineral supplements were primarily administered through a Y-line or directly in the activated bag. In all, 199 additions (mainly sodium, 95%) were made to the Ped3CB-A bags on 197 infusion days (23.1%) in 43 infants (44.3%). More than 1 of these nutrients was added to the bag on only 1 perfusion day. Mean and maximum parenteral nutrient intakes were 2.8 ± 0.7 and 3.6 ± 0.8 g amino acids per kilogram per day, and 80 ± 20 and 104 ± 22 kcal · kg(-1) · day(-1). Mean weight gain represented 10.0, 21.5, and 22. 6 g · kg(-1) · day(-1) according to age at inclusion (0-3, 4-7, or >7 days of life). A visual analog scale was completed and produced positive results. No adverse events were attributable to the design of the Ped3CB-A system.
Ped3CB-A provides easy-to-use, well-balanced, and safe nutritional support. Nutritional intakes and weight gain were within the recent PN recommendations in preterm infants.
Background
Recently conducted randomised controlled trials (RCTs) suggest that late commencement of parenteral nutrition (PN) may have clinical benefits in critically ill adults and children. ...However, there is currently limited evidence regarding the optimal timing of commencement of PN in critically ill term and late preterm infants.
Objectives
To evaluate the benefits and safety of early versus late PN in critically ill term and late preterm infants.
Search methods
We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (5 April 2019), MEDLINE Ovid (1966 to 5 April 2019), Embase Ovid (1980 to 5 April 2019), EMCare (1995 to 5 April 2019) and MEDLINE via PubMed (1966 to 5 April 2019). We searched for ongoing or recently completed clinical trials, and also searched the grey literature and reference lists of relevant publications.
Selection criteria
We included RCTs comparing early versus late initiation of PN in term and late preterm infants. We defined early PN as commencing within 72 hours of admission, and late PN as commencing after 72 hours of admission. Infants born at 37 weeks' gestation or more were defined as term, and infants born between 34 and 36+6 weeks' gestation were defined as late preterm.
Data collection and analysis
Two review authors independently selected the trials, extracted the data and assessed the risk of bias. Treatment effects were expressed using risk ratio (RR) and risk difference (RD) for dichotomous outcomes and mean difference (MD) for continuous data. The quality of the evidence was assessed using the GRADE approach.
Main results
Two RCTs were eligible for inclusion. Data were only available from a subgroup (including 209 term infants) from one RCT in children (aged from birth to 17 years) conducted in Belgium, the Netherlands and Canada. In that RCT, children with medium to high risk of malnutrition were included if a stay of 24 hours or more in the paediatric intensive care unit (PICU) was expected. Early PN and late PN were defined as initiation of PN within 24 hours and after day 7 of admission to PICU, respectively. The risk of bias for the study was considered to be low for five domains and high for two domains.
The subgroup of term infants that received late PN had significantly lower risk of in‐hospital all‐cause mortality (RR 0.35, 95% confidence interval (CI) 0.14 to 0.87; RD ‐0.10, 95% CI ‐0.18 to ‐0.02; number needed to treat for an additional beneficial outcome (NNTB) = 10; 1 trial, 209 participants) and neonatal mortality (death from any cause in the first 28 days since birth) (RR 0.29, 95% CI 0.10 to 0.88; RD ‐0.09, 95% CI ‐0.16 to ‐0.01; NNTB = 11; 1 trial, 209 participants).
There were no significant differences in rates of healthcare‐associated blood stream infections, growth parameters and duration of hospital stay between the two groups. Neurodevelopmental outcomes were not reported. The quality of evidence was considered to be low for all outcomes, due to imprecision (owing to the small sample size and wide confidence intervals) and high risk of bias in the included studies.
Authors' conclusions
Whilst late commencement of PN in term and late preterm infants may have some benefits, the quality of the evidence was low and hence our confidence in the results is limited. Adequately powered RCTs, which evaluate short‐term as well as long‐term neurodevelopmental outcomes, are needed.
For parenteral nutrition (PN) of newborns, the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) 2018 guidelines recommend standardized solutions over individual PN ...(IPN) solutions for most patients. This retrospective study assessed if a shift from IPN to standardized PN was feasible at the UZ Brussel. Using prescription data of 145 neonates, we calculated the nutrient provision for IPN and for standardized PN of the same volumes. We compared the macronutrient intakes with ESPGHAN 2018 recommendations to assess the feasibility. For neonates of a gestational age (GA) <32 or >36 weeks, standardized PN reached recommendations as least as fast as IPN. For neonates with a GA of 32 to 36 weeks, the administration protocol requires further adjustments as amino acid provision was lacking compared to IPN. Overall, the results support the feasibility of a shift from IPN to standardized PN at the UZ Brussel.
Objetive: to quantify the number of neonates treated with individualized parenteral nutrition (IPN) who were candidates to receive standardized parenteral nutrition (SPN), and to calculate their ...treatment duration. Material and methods: this was a prospective, observational, descriptive cohort study. Inclusion criteria were: neonates with indication of parenteral nutrition (PN) and individualized prescription. Exclusion criteria included: patients who had not started diuresis, with specific nutritional needs, altered acid-base balance, and/or contraindication to receive SPN. Included variables were patient-related (gender, weight, weeks of gestation, and days of life) and treatment-related regarding IPN composition. Setting the volume of PN as the conversion criterion, theoretical contributions were calculated with the SPN. The criterion for a patient to be a candidate to receive SPN was that all the theoretical contributions calculated were within the reference requirements range. Results: a total of 33 neonates (9 women) received IPN with 94 prescriptions. The median weight of the patients included in the study was 2.14 (IQR, 0.9) kg, and they were born at 35 (IQR, 3) weeks of gestation. PN began between 0 and 4 days of life. In all, 71 % (22/31) of the patients in 54.1 % of their (46/85) prescriptions were candidates to receive SPN via central administration for 1 to 8 days, whereas no patient was candidate to receive SPN via peripheral administration. Conclusions: in our center, 71 % of neonates treated with central administration of IPN are candidates to receive SPN, thus promoting the normalization of nutritional support in this population.
A.S.P.E.N. Clinical Guidelines Boullata, Joseph I.; Gilbert, Karen; Sacks, Gordon ...
JPEN. Journal of parenteral and enteral nutrition,
03/2014, Letnik:
38, Številka:
3
Journal Article
Recenzirano
Odprti dostop
Background: Parenteral nutrition (PN) is a high-alert medication available for patient care within a complex clinical process. Beyond application of best practice recommendations to guide safe use ...and optimize clinical outcome, several issues are better addressed through evidence-based policies, procedures, and practices. This document provides evidence-based guidance for clinical practices involving PN prescribing, order review, and preparation. Method: A systematic review of the best available evidence was used by an expert work group to answer a series of questions about PN prescribing, order review, compounding, labeling, and dispensing. Concepts from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) format were applied as appropriate. The specific clinical guideline recommendations were developed using consensus prior to review and approval by the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. The following questions were addressed: (1) Does education of prescribers improve PN ordering? (2) What is the maximum safe osmolarity of PN admixtures intended for peripheral vein administration? (3) What are the appropriate calcium intake and calcium-phosphate ratios in PN for optimal neonatal bone mineralization? (4) What are the clinical advantages or disadvantages of commercially available premade (“premixed”) multichambered PN formulations compared with traditional/customized PN formulations? (5) What are the clinical (infection, catheter occlusion) advantages or disadvantages of 2-in-1 compared with 3-in-1 PN admixtures? (6) What macronutrient dosing limits are expected to provide for the most stable 3-in-1 admixtures? (7) What are the most appropriate recommendations for optimizing calcium (gluconate) and (Na- or K-) phosphate compatibility in PN admixtures? (8) What micronutrient contamination is present in parenteral stock solutions currently used to compound PN admixtures? (9) Is it safe to use the PN admixture as a vehicle for non-nutrient medication delivery? (10) Should heparin be included in the PN admixture to reduce the risk of central vein thrombosis? (11) What methods of repackaging intravenous fat emulsion (IVFE) into smaller patient-specific volumes are safe? (12) What beyond-use date should be used for (a) IVFE dispensed for separate infusion in the original container and (b) repackaged IVFE?
Summary
Background
The catheter lock solutions 2% taurolidine and 0.9% saline are both used to prevent catheter‐related bloodstream infections (CRBSIs) in home parenteral nutrition patients.
Aims
To ...compare the effectiveness and safety of taurolidine and saline.
Methods
This multicentre double‐blinded trial randomly assigned home parenteral nutrition patients to use either 2% taurolidine or 0.9% saline for 1 year. Patients were stratified in a new catheter group and a pre‐existing catheter group. Primary outcome was the rate of CRBSIs/1000 catheter days in the new catheter group and pre‐existing catheter group, separately.
Results
We randomised 105 patients, of which 102 were analysed as modified intention‐to‐treat population. In the new catheter group, rates of CRBSIs/1000 catheter days were 0.29 and 1.49 in the taurolidine and saline arm respectively (relative risk, 0.20; 95% CI, 0.04‐0.71; P = 0.009). In the pre‐existing catheter group, rates of CRBSIs/1000 catheter days were 0.39 and 1.32 in the taurolidine and saline arm respectively (relative risk, 0.30; 95% CI, 0.03‐1.82; P = 0.25). Excluding one outlier patient in the taurolidine arm, mean costs per patient were $1865 for taurolidine and $4454 for saline (P = 0.03). Drug‐related adverse events were rare and generally mild.
Conclusions
In the new catheter group, taurolidine showed a clear decrease in CRBSI rate. In the pre‐existing catheter group, no superiority of taurolidine could be demonstrated, most likely due to underpowering. Overall, taurolidine reduced the risk for CRBSIs by more than four times. Given its favourable safety and cost profile, taurolidine locking should be considered as an additional strategy to prevent CRBSIs.
Trial registration: Clinicaltrials.gov, identifier: NCT01826526.
Parenteral nutrition (PN) has become an integral part of clinical management of very low birth weight premature neonates. Traditionally different components of PN are prescribed individually ...considering requirements of an individual neonate (IPN). More recently, standardised PN formulations (SPN) for preterm neonates have been assessed and may have advantages including better provision of nutrients, less prescription and administration errors, decreased risk of infection, and cost savings. The recent introduction of triple-chamber bag that provides total nutrient admixture for neonates may have additional advantage of decreased risk of contamination and ease of administration.
Background: Parenteral nutrition (PN) administered via central venous catheter has been identified as an independent risk factor for central line–associated bloodstream infections (CLABSIs). The aim ...of this study was to provide an updated description of the relationship between PN and CLABSI and assess temporal trends in CLABSI rates for individuals who received PN from 2009–2014, after the Centers for Medicare & Medicaid declared CLABSI a “never event.” Methods: Using data obtained from all adult patient discharges between January 1, 2009, and December 31, 2014, from 2 affiliated hospitals in a large health system in New York City, univariate and multivariate analyses were performed to examine the relationship between PN and CLABSIs as well as temporal trends. Results: Among 38,674 patients with central lines, 3517 developed CLABSIs and 767 patients were prescribed PN. PN was an independent risk factor for developing CLABSI among our patients (odds ratio OR, 2.65; 95% confidence interval CI, 2.20–3.19). The incidence of CLABSI among patients who were prescribed PN was not significantly different across the years of this study, even after adjusting for severity of illness. Conclusion: PN remains a significant risk factor for CLABSIs; further work is needed to identify effective strategies to reduce rates of CLABSI among patients receiving PN.
Summary Background Home parenteral nutrition (HPN) is the mainstay of treatment for patients with Type 3 intestinal failure (IF), however long term data on mortality and nutritional outcomes are ...limited. Objectives To assess the long-term survival and requirements for ongoing HPN in patients receiving treatment at a UK national referral centre for intestinal failure. Methods Patients with IF who received HPN for more than 3 months at this Intestinal Failure Unit between 1978 and 2011 had their clinical records reviewed. SPSS 20 was utilised to perform Cox regression analysis and generate Kaplan Meier curves, with the aim of identifying factors associated with death and the continued need for HPN. Results Case notes from 545 patients were reviewed. Overall survival (OS) in patients without malignancy at commencement of IF was 93%, 71%, 59% and 28% at 1, 5, 10 and 20 years after starting treatment. Crohn's disease, mesenteric ischaemia and chronic intestinal pseudo-obstruction were associated with a better OS than scleroderma and radiation enteritis on multivariate analysis. Older age at onset of IF was associated with poor OS, while shorter small bowel length or central line sepsis was not. 15% (25/170) of deaths were due to complications of HPN (central line sepsis = 10, IF-associated liver disease = 15). Continued HPN dependence in survivors was 83%, 63%, 59% and 53% at 1, 5, 10 and 15 years, respectively. Among the 153 patients without malignancy who achieved nutritional independence from HPN, 77 (50.3%) did so after surgical reconstruction of the alimentary tract (HPN duration mean 19 months, range 3–126 months). 76 patients (49.7%) weaned from HPN without undergoing surgical reconstruction. Conclusion This is the largest reported data set on long-term survival and dependence on HPN and will inform the indications, benefits and risks of treatment in disease specific groups. A significant proportion of patients achieved nutritional autonomy without surgical intervention.
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